Background Tenofovir alafenamide (TAF) is a new molecule that is being replaced for TDF, the original formulation of tenofovir (TDF), because of its improved efficacy and safety profile in HIV patients.
Purpose To analyse efficacy and renal safety of TAF/FTC/EVG/cobi antiretroviral therapy (ART) in real clinical practice.
Material and methods Retrospective study including all patients who started treatment with TAF/FTC/EVG/cobi from June 2016 to May 2017. Patients were divided into two subgroups: naive and pretreated with other ARTs patients. To determine effectiveness, plasma-HIV RNA (viral load) and CD4-T-lymphocyte (CD4) cell count were measured, and to analyse renal safety, glomerular filtration rate (GFR) and urinary protein to creatinine ratio were measured at baseline and after 6 months’ treatment. Viral load <20 copies/ml was considered as effective. Renal involvement was considered if GFR <60 ml/min. Sources of information: athosPRISMA™ (patient selection) and Diraya-Clinical-Station (analytical data).
Results Ninety-eight patients were analysed, 80% were males and mean age was 46 years. Naive-subgroup: eight patients (8%). After 6 months’ treatment, six of eight patients reduced their baseline viral load to <20 copies/ml. Mean CD4 ratio increased from an average of 181 to 221 cel/µL. Mean baseline GFR decreased from an average of 115 ml/min to 107.3 ml/min (7%) after 6 months’ treatment. Urinary protein to creatinine ratio worsened in one patient and improved in another after 6 months’ treatment. The rest of the patients remained at normal levels. Pretreated subgroup: 90 patients (92%). 68 patients had <20 copies/ml at baseline and also after 6 months’ therapy. Twenty-two patients had an average of 37 500 copies/ml, and 16 of these patients reduced their viral load to <20 copies/ml after 6 months’ treatment. The average CD4 count increased from 623 to 700 cel/µL in all patients. Mean GFR at baseline was 98.5 ml/min and did not change after treatment with TAF/FTC/EVG/cobi. The urinary protein to creatinine ratio worsened in two of 90 patients and improved in six patients after 6 months’ treatment. The rest of the patients remained at normal levels. Of all analysed patients, no one had renal involvement.
Conclusion TAF/FTC/EVG/cobi therapy was described to be effective and safe in both naive and pretreated patients in clinical practice.
Reference and/or Acknowledgements 1. European Medicines Agency. Genvoya Product Information. Consulted: 13 October 2017.
No conflict of interest
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